gmp quality assurance
Post on 07-May-2015
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Hardik Mistry
Quality Square
Quality Square Industry Ltd
Quality Square Industry Ltd
Quality Assurance Training
Quality assurance is a wide ranging concept covering all matters that individually or collectively influence the quality of a product.
It is the totality of the arrangements made with the object of ensuring that pharmaceutical products are of the quality required for their intended use.
QA is the heart and soul of quality control
QA = QC + GMP /Other Quality Systems
Introduction
Quality Square Industry Ltd
Quality Assurance
Quality Square Industry Ltd
Raw Material
Processing
Equipments
Manufacturing Plant
Operators
Environment
Manufacturing
In Process
Testing
Finish Product
Packaging
Storage
Dispatch
Customer
TOP Management
Statistical Analysis
Strict CAPA
Failure Analysis
APR
APQR
Deviation Management
Change Control
OOS Management
Customer Complaint
Validation
Manufacturer (ME) sales my product to the Customer by saying that this product is intended for this with this this and this Quality. And you will he happy and satisfied by my Product.
Now its my responsibility to assure the supply of the claimed Quality (this, this and this) product to the customer.
But by just controlling Manufacturing operation or person…..I can never assure my customers about Quality which I claimed.
I must have to look and control over everything related to the making of product like Raw Material Quality Ancillary Material Quality Operational Quality Equipment and Instrument Quality Persons engaged in whole operation (Store, QC, QA, Production, Logistics, IT) Manufacturing and testing Quality etc..
Where QA is Born….?
Quality Square Industry Ltd
If I miss to take care any of them, then I cannot give the assurance of my product.
And if customer is not happy by my product, I will lose him…….
So to make my customer Happy and Satisfied with my product……Quality Assurance will work over overall manufacturing of my Product.
Quality Square Industry Ltd
FINE QUALITY INPUT ONLY CAN GIVE YOU A FINE QUALITY OUTPUT.
QUALITY ASSURANCE
Quality Square Industry Ltd
ISO (International Organization for
Standardization) It work in favor of customer
Its focus is on product Quality ISO consists more Business operations
Optional
GMP (Good Manufacturing Practice)
It works in favor of Manufacturer Its focus is on Manufacturing
GMP consists of more technical operationsMandatory
If you have GMP 20 – 30 % more work needed to get ISOIf you have ISO 65 – 75 % more work needed to get GMP
That work and required more work will be the great effort of the QUALITY ASSURANCE
ISO/GMP
Quality Square Industry Ltd
Quality Assurance is a dynamic process
It is a journey towards the destination
According to QA, products are designed and developed in a way that takes account of the requirements of GMP and other associated codes such as those of good laboratory practice (GLP) and good clinical practice (GCP).
Product and control operations are clearly specified in a written form and GMP requirements are adopted.
Arrangements are made for the manufacture, supply and use of the correct starting and packaging materials.
All necessary controls on starting materials, intermediate products, and bulk products and other in-process controls, calibrations, and validations are carried out.
Quality Assurance Highlights
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The finished products is correctly processed and checked according to the defined procedures.
Products are not sold or supplied before the authorized persons have certified that each production batch has been produced and controlled in accordance with the requirements of the marketing authorization and any other regulations relevant to the production, control and release of products.
Satisfactory arrangements exist to ensure, as far as possible, that the pharmaceutical products are stored by the manufacturer, distributed and subsequently handled so that quality is maintained throughout their shelf-life.
There is a procedure for self-inspection and/or quality audit that regularly appraises the effectiveness and applicability of the quality assurance system.
Cont….
Quality Square Industry Ltd
Regular evaluations of the quality of pharmaceutical products should be conducted with the objective of verifying the consistency of the process and ensuring its continuous improvement.
Evaluation and Analysis of the Deviations, Out of Specification results and Change Controls during the Manufacturing
Complaint handling
Documentation of the process from staring material to the end user and its storage.
Stability studies
Registration of documents
Cont….
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Man
Material
Machinery
Manuals/Methodology ( SOP)
Motivation
The 5 M’s of Quality
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Pre analytical Analytical Post analytical
Right specimen Laboratory professionals
Recording
Right collection Reagents Interpretation
Right labeling Equipment Turnaround time
Right quantity Selection of test - SOP
Report to right user
Right transport Records
Right storage Bio-Safety
Factors influencing Quality
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1.Technology transfer
2. Validation
3. Documentation
4. Assuring quality of products
5. Quality improvement plans
QA Activities
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1 – Technology transfer
Receipt of product design documents from research centre
Receipt of the trial and error data and its final evaluation
Distribution of documents received from research centre
Checking and approval of documents generated based on research centre documents i.e. batch manufacturing record
Scale-up and validation of product
Cont….
Quality Square Industry Ltd
2– Validation
Preparation of Validation Master plans for facility/equipments/process Utility, Cleaning and all the sections of the validation
Approval of protocol for validation of facility/ equipment/product/ process/Utility
Team member for execution of validation of facility/equipment / product/ process
Final approval of the facility/ equipment/product/ process/Utility validation
Cont….
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Main objective To establish, monitor and record “Quality” for all aspects of
Good Manufacturing Practices (GMP) and other Quality System pertaining
Type of documents Standard operating procedures Protocols of tests, Results Reports
Documentation
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Laboratory records
Description and identification of sample received Description of method of testing Record of all data secured in the course of the test Record of test results and how they compare with standards of
identity, strength and quality Record of all deviations and modification of test Record of standardization of reference standards Record of calibration of equipments
“ IF you have not documented itYou have not done it”
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3 – Documentation Control
Controlled distribution and archiving of documents
Control of changes made by proper change control procedure
Approval of all documents
Cont….
Quality Square Industry Ltd
An authorized written procedure giving instructions for performing operations not necessarily specific to a given process, product or material (e.g. equipment operation, maintenance and cleaning; validation; cleaning of premises and environmental control; sampling and inspection).
Standard Operating Procedure(SOPs)
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Standard operating procedures describe in a detailed form the activities performed in the laboratory
Provide uniformity, consistency and reliability in each of the activities performed in the laboratory
Reduce systematic errors
Provide training and guidance for new staff
Cont…
Quality Square Industry Ltd
Written instructions that specify how a test or procedures is to be performed.
How a piece of equipment is operated, maintained and calibrated. Describes “Standard” approved procedures. Revision … when planned changes are made or annually Original – maintained in a central file. Copies – distributed to locations. Written by the person performing the procedure or who knows the
procedure well. Supervisor review SOPs for completeness and content. QA or QC staff approval
SOPs should be….
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4 – Assuring Quality of products
CGMP training SOP compliance Audit of facility for compliance Line clearance In-process counter checks Critical sampling Record verification Release of batch for marketing Investigation of market complaints
Cont….
Quality Square Industry Ltd
5 –Quality improvement plan
Feedback received from the compliance team Customer complaint history Proposals for corrective and preventive actions Annual Products review Trend analysis of various quality parameters for products,
environment and water Review of the Deviations, Change Controls, Out Of
Specifications and Failures.
Cont….
Quality Square Industry Ltd
Raw Material Packaging Material
Receipt
Verification
Sampling
Under Test
QC Testing
Approved Rejected
For ManufacturingReturn to Supplier/
Destruction
Flow Chart RM/PM Inspection
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Completion of batch of Finished Products
Sampling by QA
Under Test
QC Testing
Preparation of Report And Checking
Approved Rejected
For ManufacturingReprocess/Destruction
Flow Chart Finished Product Inspection
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Received In process requisition along with
sample
Testing as per specs or Requisition Sampling
by QA
Results conveyed to production
Flow Chart In process Check
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Quality Assurance
ProcedureUse
Storage/Distribution
Selection
National Drug Policy & Legal Framework
- Quality requirement- Drug Registration
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QA Verificati
on
Business - Establish if the company is manufacturer or wholesaler;- Assess the size of business in terms of staff. Capital value, Sales turnover. etc.
Manufacturing
- Ensure GMP compliance- WHO Certification can be used;- Crosscheck with QA system description
Quality
- Evaluate QA System:- GMP requires companies to have QC laboratories
Product
Formulate decision from- Regulatory status of a product with well- established DRS;- WHO Certification Scheme; -Therapeutic equivalence
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Standards are the key to effective quality managementThey may be international, national, organizational or project
standards.
Product standards Process standards In process Standards Raw material and Packaging Material Standards Testing Standards Equipment and Instrument Standards Working and Reference Standards
Quality Assurance and Standards
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Encapsulation of best practice- avoids repetition of past mistakes.
They are a framework for quality assurance processes - they involve checking compliance to standards.
They provide continuity - new staff can understand the organisation by understanding the standards that are used.
Importance of Standards
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Particularly important - documents are the tangible manifestation of the softcopies.
Documentation process standardsConcerned with how documents should be developed, validated and maintained.
Document standardsConcerned with document contents, structure, and appearance.
Document interchange standardsConcerned with the compatibility of electronic documents.
Document identification standardsHow documents are uniquely identified.
Document structure standardsStandard structure for project documents.
Document presentation standardsDefine fonts and styles, use of logos, etc.
Document update standardsDefine how changes from previous versions are reflected in a document.
Documentation Standards
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A quality plan sets out the desired product qualities and how these are assessed and defines the most significant quality attributes.
The quality plan should define the quality assessment process. It should set out which organisational standards should be applied
and, where necessary, define new standards to be used.
• Quality plan structure• Product introduction;• Product plans;• Process descriptions;• Quality goals;• Risks and risk management.
• Quality plans should be short, succinct documents• If they are too long, no-one will read them.
Quality Planning
Quality plans
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• Component of a QA program• Procedure control• QC process involves checking all the operational procedures to
make certain they are performed correctly• The QC chemists must ensure that they meet standards at all
times
• Right to test all the levels….No evaluation of the result• QA will evaluate the all the testing results at all the levels and give
approval for the further process.
Quality Control
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This is the principal method of validating the quality of a process or of a product.
A group examines part or all of a process or system and its documentation to find potential problems.
There are different types of review with different objectives Annual Product Review Annual Product Quality Review Document Review
Quality Review
Quality Square Industry Ltd
Comments made during the review should be classified
No action No change to the Product, Process or Document
Refer for ImproveShould correct an identify root cause of the problem
Reconsider overall designSome overall judgement must be made about the most cost-effective way of solving the problem;
Review results
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Selection Purchase / Acquisition Installation Calibration /Validation Maintenance - Service and repair Replacement
Quality Assurance Equipment Criteria
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Everyone is Quality Assurance
Quality Square Industry Ltd
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